Clanderón 37.5 mg/325 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Clanderon 37.5 mg / 325 mg film-coated tablets EFG

tramadol hydrochloride/paracetamol

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed only for you; do not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Clanderon is and what it is used for
2. What you need to know before taking Clanderon
3. How to take Clanderon
4. Possible side effects
5. How to store Clanderon
6. Contents of the pack and other information

1. What Clanderon is and what it is used for

Clanderon is a combination of two analgesics, tramadol and paracetamol, which work together to relieve pain.

Clanderon is indicated for the symptomatic treatment of moderate to severe pain, when your doctor considers that the combination of tramadol and paracetamol is necessary.

Clanderon should only be used by adults and adolescents over 12 years of age.

2. What you need to know before starting to take Clanderon

Do not take Clanderon:

• if you are allergic to tramadol hydrochloride, paracetamol, or any of the other ingredients of this medicine (listed in section 6);
• if you have taken medicines for insomnia, strong painkillers (opioids), or psychotropic medicines (medicines that may alter mood and emotions) in case of acute alcohol intoxication;
• if you are currently taking monoamine oxidase inhibitors (MAOIs) (certain medicines used to treat depression or Parkinson's disease) or have taken them within the last 14 days before starting treatment with Clanderon;
• if you have severe liver disease;
• if you have epilepsy that is not adequately controlled with your current treatment.

Warnings and precautions

Talk to your doctor before starting to take Clanderon:

• if you are taking other medicines containing paracetamol or tramadol;
• if you have liver problems or liver disease, or if you notice that your eyes or skin turn yellow. This may indicate jaundice or problems with your bile ducts;
• if you have kidney problems;
• if you have severe breathing difficulties, for example asthma or serious lung conditions;
• if you have epilepsy or have had seizures or convulsions;
• if you have recently suffered a head injury, shock, or severe headaches associated with vomiting;
• if you are dependent on any other pain-relief medicine, for example morphine;
• if you are taking other pain medicines containing buprenorphine, nalbuphine, or pentazocine;
• if you are due to undergo anesthesia. Inform your doctor or dentist that you are taking tramadol/paracetamol;
• if you suffer from depression and are taking antidepressants, as some may interact with tramadol (see “Other medicines and Clanderon”).

During treatment with tramadol/paracetamol, inform your doctor immediately if:

You have serious conditions such as severe renal failure or sepsis (when bacteria and their toxins circulate in the blood, causing organ damage), or if you suffer from malnutrition, chronic alcoholism, or are also taking flucloxacillin (an antibiotic). A serious condition called metabolic acidosis (an abnormality in blood and body fluids) has been reported in patients under these circumstances when paracetamol is used regularly over a prolonged period or when paracetamol is taken together with flucloxacillin. Symptoms of metabolic acidosis may include: severe breathing difficulties with deep and rapid breathing, drowsiness, feeling unwell (nausea), and vomiting.

There is a low risk that you may experience a serotonin syndrome, which may occur after taking tramadol in combination with certain antidepressants or tramadol used as monotherapy. Contact your doctor immediately if you experience any symptoms related to this serious condition (see section 4 “Possible side effects”).

Sleep-related breathing disorders

Clanderon may cause sleep-related breathing disorders such as central sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). These symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, consult your doctor. Your doctor may consider reducing the dose.

Tramadol is metabolized in the liver by an enzyme. Some people have a variation of this enzyme, which may affect individuals differently. In some people, adequate pain relief may not be achieved, while others may be more likely to experience serious adverse effects. If you notice any of the following adverse effects, you must stop taking this medicine and contact a doctor immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, general malaise or vomiting, constipation, or loss of appetite.

Inform your doctor or pharmacist if you experience any of the following symptoms while taking Clanderon:

Extreme fatigue, loss of appetite, severe abdominal pain, nausea, vomiting, or low blood pressure. These may indicate adrenal insufficiency (low cortisol levels). If you experience any of these symptoms, inform your doctor, who will decide whether you need hormonal supplementation.

Tolerance, dependence, and addiction

This medicine contains tramadol, which is an opioid medicine. Repeated use of opioids may cause the medicine to become less effective (you become accustomed to it, known as tolerance). Repeated use of tramadol/paracetamol may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use.

Dependence or addiction may make you feel that you no longer control how much medicine you need to take or how often you take it.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to tramadol/paracetamol if:

• You or a family member has abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have previously had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental illnesses.

If you notice any of the following signs while taking tramadol/paracetamol, it could indicate that you have become dependent or addicted:

• You need to take the medicine for longer than advised by your doctor.
• You need to take more than the recommended dose.
• You use the medicine for reasons other than prescribed, for example, “to stay calm” or “to sleep”.
• You have repeatedly tried and failed to stop or control your use of the medicine.
• When you stop taking the medicine, you feel unwell, and you feel better when you take it again (“withdrawal effect”).

If you notice any of these signs, talk to your doctor so they can advise you on the best treatment approach, including when it is appropriate to stop taking the medicine and how to do so safely (see section 3, “If you stop taking Clanderon”).

Children and adolescents

Treatment is not recommended in children under 12 years of age.

Use in children with breathing problems

The use of tramadol is not recommended in children with breathing problems, as symptoms of tramadol toxicity may worsen in these children.

Other medicines and Clanderon

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Important: This medicine contains paracetamol and tramadol. Inform your doctor if you are taking any other medicine containing paracetamol or tramadol, so that you do not exceed the maximum daily dose.

Clanderon must not be taken together with monoamine oxidase inhibitors (MAOIs) (see section “Do not take Clanderon”).

The use of Clanderon is not recommended if you are being treated with:

• Carbamazepine (a medicine usually used to treat epilepsy or certain types of pain, such as severe facial pain called trigeminal neuralgia).
• Buprenorphine, nalbuphine, or pentazocine (opioid analgesics). Pain relief may be reduced.
• Flucloxacillin (an antibiotic), due to a serious risk of blood and fluid abnormalities (called metabolic acidosis) that must be treated urgently (see section 2).

The risk of adverse effects increases:

• If you are taking triptans (for migraine treatment) or selective serotonin reuptake inhibitors (SSRIs) (for depression treatment). If you experience confusion, agitation, fever, sweating, uncoordinated eye or limb movements, uncontrollable muscle contractions, or diarrhea, contact your doctor immediately.

• If you are taking other analgesics such as morphine and codeine (also when used to treat cough), baclofen (a muscle relaxant), certain medicines to lower blood pressure, or medicines for treating allergies. You may feel drowsy or dizzy. If this occurs, consult your doctor.

• If you are taking gabapentin or pregabalin for treating epilepsy or nerve-related pain (neuropathic pain).

• The concomitant use of Clanderon and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be potentially fatal. For this reason, concomitant use should only be considered when no other treatment options are possible. However, if your doctor prescribes this medicine together with sedative medicines, your dose and duration of concomitant treatment should be limited.

Inform your doctor of all sedative medicines you are taking and strictly follow your doctor’s dosage recommendations. It may be helpful to inform your friends and family about the signs and symptoms listed above. Inform your doctor if you experience any of these symptoms.

• If you are taking medicines that may trigger or facilitate seizures, such as certain antidepressants or antipsychotics. The risk of seizures increases if you take Clanderon simultaneously with these medicines. Your doctor will advise whether Clanderon is suitable for you.

• If you are taking antidepressants, Clanderon may interact with these medicines and you may experience serotonin syndrome (see section 4 “Possible side effects”).

• If you are taking warfarin or phenprocoumon (medicines used to prevent blood clots). The effectiveness of these medicines may be altered, increasing the risk of bleeding. You must inform your doctor immediately of any prolonged or unexpected bleeding.

The effectiveness of Clanderon may be altered if you also take:

• metoclopramide, domperidone, or ondansetron (medicines used to treat nausea and vomiting),
• colestyramine (a medicine that lowers blood cholesterol).

Your doctor will know which medicines are safe to use with Clanderon.

Taking Clanderon with food, drinks, and alcohol

Clanderon may make you feel drowsy. Alcohol may also cause drowsiness; therefore, it is recommended not to drink alcohol while taking Clanderon.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Because Clanderon contains tramadol, it is not recommended to take this medicine during pregnancy or breastfeeding. If you become pregnant while taking Clanderon, consult your doctor before taking the next tablet.

Breastfeeding

Tramadol is excreted in breast milk. Therefore, you should not take Clanderon more than once during breastfeeding, or if you take Clanderon more than once, you must stop breastfeeding.

Based on human experience, there is no indication that tramadol affects fertility in men and women. No data are available on the combination of tramadol and paracetamol regarding fertility.

Driving and using machines

Ask your doctor whether you can drive or operate machinery while being treated with Clanderon. It is important to observe how this medicine affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred vision or double vision, or have difficulty concentrating. Take special care at the beginning of treatment, after a dose increase, after a change in formulation, and/or when taken together with other medicines.

Use in athletes

This medicine may result in a positive doping test.

Clanderon contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Clanderon

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will explain to you what you can expect from using tramadol/paracetamol, when and for how long you should take it, when you should contact your doctor, and when you should discontinue it (see also section 2).

You should take tramadol/paracetamol for the shortest time possible. This medicine is not recommended for use in children under 12 years of age.

The dose should be adjusted according to the intensity of pain and your individual sensitivity. Normally, the lowest effective dose that provides pain relief should be used.

Unless your doctor prescribes otherwise, the recommended starting dose for adults and adolescents over 12 years of age is 2 tablets.

If necessary, the dose may be increased, as advised by your doctor.

The shortest interval between doses must be at least 6 hours.

Do not take more than 8 tablets of tramadol/paracetamol per day.

Do not take tramadol/paracetamol more frequently than instructed by your doctor.

Elderly patients

In elderly patients (over 75 years of age), elimination of tramadol may be slow. If this applies to you, your doctor may recommend prolonging the dosing intervals.

Patients with hepatic or renal impairment/patients on dialysis

If you have severe liver or kidney disease, treatment with this medicine is not recommended. If you have moderate liver or kidney disorders, your doctor may recommend prolonging the dosing intervals.

Method of administration

This medicine is available as tablets for oral administration.

The tablets should be swallowed whole with sufficient liquid. They must not be broken or chewed.

If you feel that the effect of tramadol/paracetamol is too strong (e.g., you feel very drowsy or have difficulty breathing) or too weak (e.g., you do not get adequate pain relief), inform your doctor.

If you take more Clanderon than you should

If you have taken more tramadol/paracetamol than you should, even if you feel well, contact your doctor or pharmacist immediately, as there is a risk of serious liver damage that may only become apparent later.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Clanderon

If you forget to take this medicine, your pain may return.

Do not take a double dose to make up for a missed dose; simply continue taking the tablets as usual.

If you stop taking Clanderon

You should not stop taking this medicine suddenly unless instructed by your doctor. If you wish to stop taking the medicine, speak to your doctor first, especially if you have been taking it for a long time. Your doctor will advise you when and how to stop, which may involve gradually reducing the dose to minimize the risk of unnecessary adverse effects (withdrawal symptoms).

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common: may affect more than 1 in 10 people

• nausea
• dizziness, drowsiness

Common: may affect 1 in 10 people

• vomiting, digestive problems (constipation, flatulence, diarrhoea), stomach pain, dry mouth
• itching, increased sweating (hyperhidrosis)
• headache, agitation
• confusion, sleep disorders, mood changes (anxiety, nervousness, euphoria – a feeling of being "high-spirited" all the time)

Uncommon: may affect 1 in 100 people

• increased pulse or increased blood pressure, disturbances in heart rhythm and rate
• tingling sensation, numbness, or prickling sensations in the limbs, ringing in the ears (tinnitus), involuntary muscle spasms
• depression, nightmares, hallucinations (hearing, seeing, or sensing something that does not exist in reality), memory loss
• difficulty breathing
• difficulty swallowing, blood in the stool
• skin reactions (e.g. rashes, urticaria)
• increased liver enzyme values
• presence of albumin in urine, difficulty or pain when urinating
• chills, hot flushes, chest pain

Rare: may affect 1 in 1,000 people

• seizures, difficulty performing coordinated movements, transient loss of consciousness (syncope)

• drug dependence

• delirium

• blurred vision, pupil constriction (miosis)

• speech disorders

• excessive dilation of the pupils (mydriasis)

• Frequency not known: cannot be estimated from available data

• decrease in blood sugar levels (hypoglycaemia)

• hiccups

• serotonin syndrome, which may present with changes in mental status (e.g. agitation, hallucinations, coma), and other effects such as fever, increased heart rate, unstable blood pressure, involuntary muscle contractions, muscle rigidity, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea) (see section 2 “What you need to know before taking Clanderon”)

The following recognised adverse effects have been reported by people who have taken medicines containing tramadol alone or paracetamol alone. However, if you experience any of these symptoms while taking Clanderon, you must inform your doctor:

• Dizziness upon standing up after lying down or sitting, slow heart rate, fainting, changes in appetite, muscle weakness, slower or weaker breathing, mood changes, changes in activity, altered perception, worsening of asthma.

• The use of tramadol/paracetamol together with anticoagulants (e.g. fenprocoumon, warfarin) may increase the risk of bleeding. You must inform your doctor immediately about any prolonged or unexpected bleeding.

• In rare cases, skin rashes indicating allergic reactions may occur, which may manifest as sudden swelling of the face and neck, shortness of breath, or drop in blood pressure and dizziness. If this happens to you, stop treatment immediately and consult your doctor without delay. You must not take this medicine again.

• Frequency not known (cannot be estimated from available data): a serious condition that may cause the blood to become more acidic (called metabolic acidosis) in patients with severe illness who are using paracetamol (see section 2).

In rare cases, using a medicine such as tramadol may lead to dependence, making it difficult to stop taking it.

Occasionally, people who have been taking tramadol for some time may feel unwell if treatment is stopped abruptly. They may feel agitated, anxious, nervous, or shaky.

They may become hyperactive, have difficulty sleeping, and experience gastrointestinal and intestinal disturbances.

Very few people may also experience panic attacks, hallucinations, unusual perceptions such as itching, tingling, numbness, and ringing in the ears (tinnitus).

If you experience any of these symptoms after stopping treatment with Clanderon, please consult your doctor.

In exceptional cases, blood tests may reveal certain abnormalities, for example low platelet count, which may result in nosebleeds or bleeding gums.

In rare cases, serious skin reactions have been reported with paracetamol.

Rare cases of respiratory depression have been reported with tramadol.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clanderon

Keep this medicine out of the sight and reach of children.

Store this medicine in a safe and secure place, where others cannot access it. It may cause serious harm or be fatal to individuals for whom it has not been prescribed.

Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

• The active substances are tramadol hydrochloride and paracetamol.

• Each film-coated tablet contains 37.5 mg of tramadol hydrochloride and 325 mg of paracetamol.

• The other components (excipients) are: microcrystalline cellulose powder, pregelatinized corn starch, sodium carboxymethylstarch (type A) (from potato), corn starch, magnesium stearate, hypromellose, titanium dioxide, talc, triethyl citrate.

Appearance of the product and contents of the pack

Clanderon 37.5 mg / 325 mg film-coated tablets EFG are white or almost white tablets.

Clanderon is presented in PVC/aluminum blisters containing 20, 30, 50, 60 and 90 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Manufacturer:

Laboratorios Medicamentos Internacionales S.A. (Medinsa)

C/Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

or

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10 - Berlin - 13435 - Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

PT: Tramadol / Paracetamol Aristo 37.5 mg / 325 mg film-coated tablets

DE: Tramadol/Paracetamol Aristo 37,5 mg / 325 mg Filmtabletten

ES: Clanderon 37.5 mg / 325 mg film-coated tablets EFG

IT: Tramadolo e Paracetamolo 37.5 mg / 325 mg compresse rivestite con film

Date of the most recent revision of this leaflet: June 2025

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/